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Comparative Effectiveness Research (CER) Toolkit

Comparative Effectiveness Research (CER) Toolkit

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Although the concepts of comparative effectiveness research (CER) and evidence-based medicine (EBM) are not new, it is important to establish a clear definition and understanding of why these are so prominent today and the many related issues and initiatives under consideration in Washington, DC. To facilitate this understanding, the National Pharmaceutical Council (NPC) has developed a series of informational pieces, which taken together provide an overview of CER and EBM. Each of the following items outlines a specific aspect in a short, easy-to-read format. Defining Evidence-Based Medicine and Comparative Effectiveness Research A Brief History of Comparative Effectiveness Research and Evidence-Based Medicine NPC’s Key Considerations on Comparative Effectiveness Research Legislative Proposals Regarding Comparative Effectiveness Research Comparison of Comparative Effectiveness Research Legislative Activities in the Context of NPC’s CER Recommendations to Institute of Medicine, Federal Coordinating Council on CER and the Agency for Healthcare Research and Quality Additional Resources NPC will provide updates to the materials on an ongoing basis.
Although the concepts of comparative effectiveness research (CER) and evidence-based medicine (EBM) are not new, it is important to establish a clear definition and understanding of why these are so prominent today and the many related issues and initiatives under consideration in Washington, DC. To facilitate this understanding, the National Pharmaceutical Council (NPC) has developed a series of informational pieces, which taken together provide an overview of CER and EBM. Each of the following items outlines a specific aspect in a short, easy-to-read format. Defining Evidence-Based Medicine and Comparative Effectiveness Research A Brief History of Comparative Effectiveness Research and Evidence-Based Medicine NPC’s Key Considerations on Comparative Effectiveness Research Legislative Proposals Regarding Comparative Effectiveness Research Comparison of Comparative Effectiveness Research Legislative Activities in the Context of NPC’s CER Recommendations to Institute of Medicine, Federal Coordinating Council on CER and the Agency for Healthcare Research and Quality Additional Resources NPC will provide updates to the materials on an ongoing basis.

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Published by: National Pharmaceutical Council on Jul 23, 2009
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1894 Preston
White
Drive,
Reston, VA
20191-5433 Phone: 703.620.6390
Fax:
703.416.0904 Web:
www.npcnow.org
Comparative Effectiveness
Research
and
Evidence-Based
Medicine:
An
lnformational
Series
from the
National
Pharmaceutical
Council
ln early 2009,
Congress
approved
and President Obama signed
into
law
the American
Recovery and
Reinvestment
Act
(ARRA),
an
economic stimulus
package
that
includes
Sf
.f
billion
for
comparativeeffectiveness
research
(CER). By
approving those
funds,
lawmakers made
it
clear
that
CER
will
be an
integral part of health
care
reform.Although the
concept
of
CER
is
not
new,
it
is
important
to
establish
a
clear
definition
and understanding
of why
it
is
so
prominent today
and
the
many
related
issues
and
initiatives
under
consideration
in
Washington.
To
facilitate this understanding,
the
National
Pharmaceutical Council
has
developed
a
series
ofinformational
pieces,
which taken
together
provide
an
overview of
CER. Each
of
the following
items
outlines
a
specific aspect
of
CER
in
a
short,
easy-to-read
format.
Defining Evidence-Based
Medicine
a
nd
Comparative
Effectiveness
Resea
rch
A Brief History
of Comparative
Effectiveness
Research
and
Evidence-Based
Medicine
NPC's
Key
Considerations
on Comparative
Effectiveness
Research
Legislative Proposals Regarding
Comparative
Effectiveness
Research
Comparison
of Comparative
Effectiveness
Research
Legislative
Activities
in
the
Context
of
NPC's
CER
Recommendations
to
lOM,
FCCCER
and
AHRQ
Additional
Resources
We encourage you
to
share
these informational
pieces
with
your
colleagues and
other
organizations
interested
in
the
issue,
as
well
as
link
to
the
pieces
on
NPC's
website, where
we
will
be
providing
updates
to the
materials on
an
ongoing
basis.For
additional
copies
of this
information,
please
contact
NPC
at info@npcnow.ors or
703-620-6390.
aaaa
a
 
1894 Preston Wh¡te
Dr¡ve, Reston, VA
20191-5433 Phone: 703.620.6390
Fax:
703.476.0904 Web:
www.npcnow.org
Defining
Evidence-Based
Medicineand Comparative
Effectiveness
Research
lntroduction
Evidence-based
medicine
(EBM)
is a
systematic approach
to
clinical problem
solving
which
allows
theintegration
of
the
best available research evidence
with
clinical expertise
and
patient values.l
Under
this
definition,
EBM
requires clinical expertise and
use
of
the
best evidence available,
but must
also consider
patient
preferences,
optimal patient outcomes,
and
the
relative
effects among
competing
alternatives.
Broadly
considered,
EBM
includes
the comparative
effectiveness
assessments
of
drugs,
treatments
and devices, and
the appropriate
interpretation of
evidence
from
these
assessments
to
support health benefit
design and medical decision-making.
EBM
is
the foundation
for
Comparative
Effectiveness
Research
(CER),
which
compares available
treatment
options utilizing
a
range
of
research
methods including randomized controlled trials,observational
studies, and
systematic
reviews,
a
structured
assessment
of
evidence available
frommultiple
primary
studies.
Another
term that
is
frequently
mentioned
with
CER
and
EBM is
health technology
assessment
(HTA).HTA
is
a
rigorous
process
of
appraisal
that
examines
the effects
and
impact of
a
health
care
technologyor
treatment.
These
assessments
inform
decision-makers
as
to the
direct
and
indirect
consequences
of
a
given
technology
or
treatment.2
Federal
Coordinatins Council
Definition
of
CER
The Federal
Coordinating
Council
for
Comparative
Effectiveness
Research
(FCCCER)
was
established
in
2009 under
the American
Recovery and Reinvestment
Act
(ARRA)
to
"coordinate comparativeeffectiveness
research
across
the
Federal
government,
The Council was charged
with
making
recommendations for the framework
and
prioritization
of
spending
for
the
S+00
m¡ll¡on
allocated
to
the
Office
of the
Secretary
[of
Health
and
Human
Services]
for
CER."3
Following
a
series
of
public listening
sessions
regarding
how
to
define
CER
and
prioritize this
research,
the
FCCCER
has
developed the following
definition
and
criteria, which it outlined
in
a
report submitted
to
Congress
on June 30, 2009:
l
sackett
DL,
Strauss
SE,
Richardson
WS,
etol.
Evidence-based
Medicine:
How
to
Practice and Teach EBM. London:
Chu
rchill-Livingstone,
2000.
2
Buckley,
T.
The
Complexities of Comparative
Effectiveness,
October
25,2OO7.
accessed
June L4, 2009.
3
Comparative
Effectiveness Research Funding: Federal
Coordinating
Council
for
Comparative
Effectiveness
Research,
http://www.hh
accessed May 26, 2009.
 
"Comparative
effectiveness research
is
the conduct
and synthesis
of
research comparing
the
benefits
and harms
of
different
interventions
and strategies
to
prevent,
diagnose,
treat
and
monitor
healthconditions in
'realworld'
settings. The purpose
of this
research
is
to
improve health outcomes
by
developing
and disseminating evidence-based
information to
patients, clinicians, and
other
decision-makers, responding
to their
expressed needs,
about which interventions
are most
effective
for
whichpatients under
specific circumstances.
"To provide this information, comparative
effectiveness research
must
assess
a
comprehensive
array
of
health-related
outcomes
for
diverse patient populations
and subgroups.
"Defined interventions compared
may
include medications,
procedures, medical and assistivedevices and technologies, diagnostic
testing,
behavioral change, and
delivery
system strategies."This research necessitates
the
development,
expansion, and
use
of
a
variety of data
sourcesand
methods
to
assess
comparative effectiveness
and
actively
disseminate
the
results."a
For a
research
project first
to
be
considered
by
the
FCCCER,
it
must meet
these
criteria:
.
"lncluded
within statutory
limits
of
Recovery Act and
FCC
definition
of
CER
.
"Potential
to
inform
decision-making by
patients,
clinicians,
or
other
stakeholders
.
"Responsiveness
to
expressed needs
of
patients,
clinicians,
or other
stakeholders
.
"Feasibility
of
research
topic
(including
time
necessary
for
research)"The
prioritization
criteria
for
scientifically meritorious
research and
investments
are:
"Potential
impact
(based
on
prevalence
of condition,
burden
of
disease,
variability
in outcomes,costs,
potential
for
increased
patient
benefit or
decreased harm)
"Potentialto
evaluate
comparative effectiveness in
diverse
populations
and
patient
subgroupsand engage
communities
in research
"Uncertainty
within
the
clinical and
public health communities
regarding
management
decisionsand
variability
in
practice"Addresses need
or
gap
unlikely
to
be
addressed
through other
organizations
"Potentialfor
multiplicative effect
(e.g,
lays
foundation
forfuture
CER
such
as
data
infrastructure
and
methods development
and
training, or
generates
additional investmentoutside government)"s
The
FCCCER
also
has
developed
a
strategic
framework
for
CER
activity
and
investments
to
categorize
current activity, identify
gaps,
and
inform
decisions
on
high
priority
recommendations.
According
to
the
FCCCER,
"This
framework
is
intended
to
support immediate
decisions
for
investment
in
CER
priorities
and
to
provide
a
comprehensive
foundation
for
longer-term
strategic decisions on
CER
priorities
and
therelated infrastructure. At the framework's core
is
responsiveness
to
expressed
needs
for
comparativeeffectiveness
research
to
inform
health
care
decision-making
by
patients,
clinicians, and
others
in
the
a
Federal
Coordinating
Council on
Comparative
Effectiveness Research Report
to
Congress,
June 30, 2009,
p.
17.
s
lbid.,
page
17.
aa

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